BIOTECHNOLOGY INNOVATION ORGANIZATION for BIOTECHNOLOGY INNOVATION ORGANIZATION

Budget/Appropriations BUD

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054-S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Renewable Chemicals/Bio-based Products ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Energy Basic Research Funding ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017

Contacted: Natl Institutes of Health (NIH); White House Office; SENATE; Natl Security Council (NSC); U.S. Trade Representative (USTR); Agriculture, Dept of (USDA); Health Resources & Services Administration (HRSA); Office of Science & Technology Policy (OSTP); Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Environmental Protection Agency (EPA)

Bills named: H.R. 5325 (114th), S. 2956 (114th), S. 2804 (114th), H.R. 5055 (114th), S. 3040 (114th), H.R. 5293 (114th), H.R. 2577 (114th), H.R. 5054 (114th), S. 3000 (114th)

Chemicals/Chemical Industry CHM

EPA Regulations on Biotechnology ---Efficient Science-Based Review of Biotech Products ---Reauthorization of Pesticide Registration Improvement Act (PRIA) ---EPA Points to Consider Guidance Document for GE Algae Funding for Renewable Chemicals/Bio-based Products ---H.R.5055 - S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Renewable Chemicals/Bio-based Products (Non-Funding) ---Implementation of the Agricultural Act of 2014 ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---Nomenclature Usage ---Pre-market Notification Review ---Reauthorization of USDA Bio-Preferred Program ---H.R. 2576: TSCA Modernization Act ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---S. 2271: The Renewable Chemical Production Tax Credit Act ---S. 696: The Safe Chemicals Act ---S. 697: Frank R. Lautenberg Chemical Safety for 21st Century Act

Contacted: Office of Science & Technology Policy (OSTP); Natl Institutes of Health (NIH); White House Office; Environmental Protection Agency (EPA); Food & Drug Administration (FDA); Agriculture, Dept of (USDA); Health Resources & Services Administration (HRSA); Centers For Medicare and Medicaid Services (CMS); U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS); SENATE; HOUSE OF REPRESENTATIVES; Natl Security Council (NSC)

Bills named: S. 2804 (114th), S. 697 (114th), S. 2271 (114th), H.R. 3390 (114th), H.R. 2576 (114th), S. 696 (114th), H.R. 5055 (114th)

Energy/Nuclear ENG

Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Implementation of the Agricultural Act of 2014 ---Production Tax Credit Extension ---S. 2658: Federal Aviation Administration Reauthorization Act of 2016 ----- Franken-Grassley Amendment Energy Basic Research Funding ---DOE Office of Science ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 Funding for Biorefineries ---Department of Defense Funding of Advanced Biofuels Renewable Fuel Standard ---H.R.5538-S.3068: Departments of Interior, and Related Agencies Appropriations Act for FY 2017 ---The 2014-2016 Final Rule ---EPA proposed rule for the Renewable Fuel Standard Program: Standards for 2017 and Biomass-Based Diesel Volume for 2018 Review of the Federal Coordinated Framework for Biotechnology Products

Contacted: Environmental Protection Agency (EPA); Natl Institutes of Health (NIH); Office of Science & Technology Policy (OSTP); Food & Drug Administration (FDA); White House Office; Agriculture, Dept of (USDA); Natl Security Council (NSC); HOUSE OF REPRESENTATIVES; SENATE; Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); Health Resources & Services Administration (HRSA); U.S. Trade Representative (USTR)

Bills named: H.R. 5538 (114th), S. 2658 (114th), S. 2804 (114th), S. 3068 (114th), S. 2956 (114th), H.R. 5293 (114th), H.R. 5055 (114th), S. 3000 (114th), H.R. 5054 (114th)

Fuel/Gas/Oil FUE

Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Implementation of the Agricultural Act of 2014 ---Production Tax Credit Extension ---S. 2658: Federal Aviation Administration Reauthorization Act of 2016 ----- Franken-Grassley Amendment Energy Basic Research Funding ---DOE Office of Science ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations Act for FY 2017 Funding for Biofuels ---H.R.5293/S.3000: Department of Defense Appropriations Act for FY 2017 ---H.R.5055/S.2804: Energy and Water Development and Related Agencies Appropriations for FY 2017 Funding for Biomass Crop Assistance Program ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 Funding for Biorefineries ---Department of Defense Funding of Advanced Biofuels Renewable Fuel Standard ---H.R.5538-S.3068: Departments of Interior, and Related Agencies Appropriations Act for FY 2017 ---The 2014-2016 Final Rule ---EPA proposed rule for the Renewable Fuel Standard Program: Standards for 2017 and Biomass-Based Diesel Volume for 2018 Review of the Federal Coordinated Framework for Biotechnology Products

Contacted: Natl Security Council (NSC); Food & Drug Administration (FDA); White House Office; SENATE; Office of Science & Technology Policy (OSTP); HOUSE OF REPRESENTATIVES; Health Resources & Services Administration (HRSA); Agriculture, Dept of (USDA); Centers For Medicare and Medicaid Services (CMS); Environmental Protection Agency (EPA); Health & Human Services, Dept of (HHS); Natl Institutes of Health (NIH); U.S. Trade Representative (USTR)

Bills named: S. 2804 (114th), H.R. 5293 (114th), S. 2956 (114th), S. 2658 (114th), S. 3000 (114th), S. 3068 (114th), H.R. 5055 (114th), H.R. 5538 (114th), H.R. 5054 (114th)

Homeland Security HOM

Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016

Contacted: HOUSE OF REPRESENTATIVES; Agriculture, Dept of (USDA); Natl Institutes of Health (NIH); SENATE; Natl Security Council (NSC); U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS); White House Office; Food & Drug Administration (FDA); Health Resources & Services Administration (HRSA); Office of Science & Technology Policy (OSTP); Environmental Protection Agency (EPA); Centers For Medicare and Medicaid Services (CMS)

Bills named: H.R. 2577 (114th), H.R. 3299 (114th), S. 2055 (114th), H.R. 5325 (114th), S. 3040 (114th)

Trade (domestic/foreign) TRD

TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization ---Ag-Biotech Issues Biosimilars ---Colombia Biologics Regulations ---Mexico Biologics Regulations Drug Importation ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Like-minded Countries Initiatives ---Asynchronous Approvals Intellectual Property International Enforcement ---Compulsory Licensing ---Colombia ---India UN High Level Commission on Access to Medicines

Contacted: HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Agriculture, Dept of (USDA); Food & Drug Administration (FDA); U.S. Trade Representative (USTR); Office of Science & Technology Policy (OSTP); Health Resources & Services Administration (HRSA); Health & Human Services, Dept of (HHS); SENATE; Environmental Protection Agency (EPA); Natl Security Council (NSC); White House Office; Natl Institutes of Health (NIH)

Bills named: H.R. 5325 (114th), S. 3040 (114th), S. 2956 (114th), H.R. 5054 (114th)

Agriculture AGR

EPA Regulations on Biotechnology ---Efficient Science-Based Review of Biotech Products ---EPA Points to Consider Guidance Document for GE Algae ---Reauthorization of Pesticide Registration Improvement Act (PRIA) Food Waste ---H.R: 4184: The Food Recovery Act Foreign Agricultural Biotechnology Laws and Regulations ---China Biotechnology Regulations ---EU Ag-Biotech Policies and Regulations ---Like-minded Countries Initiatives ---Asynchronous Approvals Funding for Biomass Crop Assistance Program ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---Implementation of the Agricultural Act of 2014 Funding for the USDA ---H.R. 5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to Restrict FDA Approval of GE Salmon ---Labeling ---S. 2634: The One Health Act ---H.R.505/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Review and Labeling of Food Derived from Biotechnology ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---S. 764: Senate biotech labeling compromise bill ---S. 2609: The Biotech Labeling Solutions Act Review of the Federal Coordinated Framework for Biotechnology Products USDA/APHIS Agricultural Biotechnology Regulations ---Co-existence of Production Systems ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations TransAtlantic Trade and Investment Partnership ---Ag-Biotech Issues Potential Regulation of New Genetic Modification Technologies

Contacted: Natl Security Council (NSC); Office of Science & Technology Policy (OSTP); U.S. Trade Representative (USTR); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); SENATE; Health Resources & Services Administration (HRSA); Agriculture, Dept of (USDA); HOUSE OF REPRESENTATIVES; Natl Institutes of Health (NIH); Food & Drug Administration (FDA); Environmental Protection Agency (EPA); White House Office

Bills named: S. 2609 (114th), S. 2956 (114th), H.R. 1599 (114th), S. 2634 (114th), S. 764 (114th), H.R. 505 (114th), H.R. 5054 (114th)

Taxation/Internal Revenue Code TAX

Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act Biofuels (Non-Funding) ---Accelerated Depreciation of Biofuels Facilities Extension ---Production Tax Credit Extension Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Inversions ---H.R.5485-S.3067: Financial Services and General Government Appropriations Act for FY 2017 Orphan Drug Act Tax Credit Renewable Chemicals/Bio-based Products (Non-Funding) ---H.R. 3390: Qualifying Renewable Chemicals Production or Investment Tax Credit Act ---Investment Tax Credit for Renewable Chemicals and Bio-based Products ---New Production Tax Credit ---S. 2271: The Renewable Chemical Production Tax Credit Act Research & Development Tax Credit Reforms ---Refundable R&D Credit

Contacted: Natl Institutes of Health (NIH); U.S. Trade Representative (USTR); Environmental Protection Agency (EPA); HOUSE OF REPRESENTATIVES; SENATE; Health & Human Services, Dept of (HHS); Agriculture, Dept of (USDA); Natl Security Council (NSC); White House Office; Office of Science & Technology Policy (OSTP); Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); Health Resources & Services Administration (HRSA)

Bills named: H.R. 5485 (114th), H.R. 3390 (114th), S. 3067 (114th), H.R. 3539 (114th), S. 2271 (114th), S. 537 (114th), H.R. 2179 (114th), S. 341 (114th)

Copyright/Patent/Trademark CPT

Bayh-Dole Act/Tech Transfer ---March-In Rights Drug Patent Settlements ---S. 2019: Preserve Access to Affordable Generics Act of 2015 Intellectual Property International Enforcement ---Compulsory Licensing ---Colombia ---India Inter Partes Review ---Implementation of the American Invents Act of 2011 ---S.1137: The PATENTS Act of 2015 Patent Reform ---H.R. 9: Innovation Act ---S.1137: The PATENTS Act of 2015 TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues UN High-Level Commission on Access to Medicines

Contacted: U.S. Trade Representative (USTR); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Office of Science & Technology Policy (OSTP); Environmental Protection Agency (EPA); Agriculture, Dept of (USDA); Centers For Medicare and Medicaid Services (CMS); White House Office; SENATE; Health Resources & Services Administration (HRSA); Natl Security Council (NSC); Natl Institutes of Health (NIH)

Bills named: S. 1137 (114th), S. 2019 (114th), H.R. 9 (114th)

Health Issues HCR

340B Drug Pricing Program ----Implementation of Affordable Care Act ---Program Implementation & Oversight ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act Biosimilars ---Biosimilar User Fee Act Reauthorization and Implementation ---Colombia Biologics Regulations ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Access to Samples for Testing ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Drug Evaluation and Review ---ADAPT Act (House Discussion Draft) ---Compassionate Use/Expanded Access ---FDA Proposed Rule on Changes to Drug Labeling ---Implementation of the FDA Safety and Innovation Act ---Reauthorization of the Prescription Drug User Fee Act Drug Importation ---H.R.5054 - S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325-S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Centers for Disease Control and Prevention Vaccine Programs ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for FDA ---H.R. 5054 -S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Orphan Drug Act Tax Credit Precision Medicine Initiative Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products -- --CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Senate Innovation for Healthier Americans ---Biomarkers and Regulatory Science Improvements ---Communication with Healthcare Professionals and Payors ---Expanded Access to Investigational Drugs ---Expedited Pathways ---FDA Hiring Flexibility ---Innovation Incentives ---Longitudinal Study of Chronic Diseases ---Patient Access to Approved Drugs ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---- S. 195: PATH Act ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act ---H.R. 4762: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act ---S. 1878: Advancing Hope Act of 2015 ---S. 2912: Trickett Wendler Right to Try Act of 2016 ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---S.524: Comprehensive Addiction and Recovery Act of 2016 ---The KIDS Act UN High Level Commission on Access to Medicines Vaccine Access/Financing ---Adult Immunization (Senate Discussion Draft) ---Senate Chronic Care Working Group Proposals ---Vaccine Injury Compensation Program ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Vaccines and Infectious Diseases - General ---H.R. 3299: Strengthening Public Health Emergency Response Act ---S.2512: Adding Zika Virus to the FDA Priority Review Voucher Program Act ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Combating Antibiotic-Resistant Bacteria (CARB) Initiative Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Vial and Dose Size Gene Editing Technologies ---S.3040-H.R.5325: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Generic Drug Entry ---S. 2615: Increasing Competition in Pharmaceuticals Act ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Government Price Reporting ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Antibiotic & Diagnostic Tax Credit ---H.R. 3539: Antibiotic & Diagnostic Innovation Act TransPacific Partnership ---Data and Intellectual Property Protection for Pharmaceuticals Transatlantic Trade and Investment Partnership ---Intellectual Property Issues ---Regulatory Harmonization

Contacted: White House Office; Natl Institutes of Health (NIH); U.S. Trade Representative (USTR); Centers For Medicare and Medicaid Services (CMS); Agriculture, Dept of (USDA); Natl Security Council (NSC); Health Resources & Services Administration (HRSA); SENATE; Health & Human Services, Dept of (HHS); Office of Science & Technology Policy (OSTP); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Environmental Protection Agency (EPA)

Bills named: S. 195 (114th), H.R. 3539 (114th), S. 2512 (114th), S. 2912 (114th), S. 2055 (114th), H.R. 5325 (114th), S. 3056 (114th), H.R. 5054 (114th), S. 1878 (114th), S. 2956 (114th), S. 524 (114th), H.R. 3299 (114th), S. 2615 (114th), H.R. 2577 (114th), H.R. 4762 (114th), S. 3040 (114th)

Small Business SMB

Capital Formation Investment Incentives ---H.R. 2179: PARTNER Act ---Reform of Capital Gains Rules ---Reform of Net Operating Loss Rules ---Reform of Passive Loss Rules ---S. 341: Start-up Jobs and Innovation Act ---S. 537: COMPETE Act Capital Market Enhancements ---H.R. 1675/S. 576: Encouraging Employee Ownership Act ---H.R. 1675: Capital Markets Improvement Act ---H.R. 2354: Streamlining Excessive and Costly Regulations Review Act ---H.R. 2357: Accelerating Access to Capital Act ---H.R. 3784/S.2867: Securities & Exchange Commission Small Business Advocate Act ---H.R. 4168: Small Business Capital Formation Enhancement Act ---H.R. 4638: Main Street Growth Act ---H.R. 2187: Fair Investment Opportunities for Professional Experts Act ---Financial CHOICE Act (House Discussion Draft) Small Business Innovation Research (SBIR) Program Proxy Advisory Services ---Impact of Policies on Small Public Companies ---H.R. 5311: The Corporate Governance Reform and Transparency Act of 2016 ---Financial CHOICE Act (House Discussion Draft) Reform of SEC Regulation D ---H.R. 4498/S.978: HALOS Act ---H.R. 4852: Private Placement Improvement Act ---Financial CHOICE Act (House Discussion Draft) Sarbanes Oxley Section 404 (b) ---H.R. 4139: Fostering Innovation Act ---PCAOB Audit Cost Increases ---Small Issuer Exemption ---Financial CHOICE Act (House Discussion Draft) Short Selling Transparency ---H.R.5485/S.3067: Financial Services and General Government Appropriations for FY 2017 XBRL Exemption for Small Public Companies ---H.R. 1675: Capital Markets Improvement Act ---H.R. 1965: Small Company Disclosure Simplification Act ---Financial CHOICE Act (House Discussion Draft) Legislative Amendments to SEC Rule 12b-2 Filing Status Definitions

Contacted: Agriculture, Dept of (USDA); U.S. Trade Representative (USTR); Centers For Medicare and Medicaid Services (CMS); SENATE; White House Office; HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Office of Science & Technology Policy (OSTP); Environmental Protection Agency (EPA); Natl Institutes of Health (NIH); Health Resources & Services Administration (HRSA); Health & Human Services, Dept of (HHS); Natl Security Council (NSC)

Bills named: H.R. 4498 (114th), H.R. 2179 (114th), S. 341 (114th), S. 978 (114th), S. 537 (114th), H.R. 4638 (114th), H.R. 4852 (114th), H.R. 2357 (114th), H.R. 2187 (114th), H.R. 5485 (114th), H.R. 3784 (114th), S. 576 (114th), H.R. 4168 (114th), S. 3067 (114th), H.R. 1675 (114th), H.R. 1965 (114th), H.R. 2354 (114th), S. 2867 (114th), H.R. 5311 (114th), H.R. 4139 (114th)

Medicare/Medicaid MMM

Government Price Reporting ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Medicaid Pricing and Rebates ---Average Manufacturer Price Calculations ---Implementation of Affordable Care Act Reimbursement for Innovative Products ---Medicare Part B Physician-Administered Products -- --CMMI Medicare Part B Proposed Demonstration Project ---Medicare Part D Prescription Drug Program ---Value-based Contracting and Communications Senate Innovation for Healthier Americans ---Patient Access to Approved Drugs

Contacted: Food & Drug Administration (FDA); Agriculture, Dept of (USDA); White House Office; Natl Institutes of Health (NIH); Environmental Protection Agency (EPA); Office of Science & Technology Policy (OSTP); SENATE; Centers For Medicare and Medicaid Services (CMS); Natl Security Council (NSC); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Health Resources & Services Administration (HRSA)

Bills named: H.R. 5325 (114th), S. 3040 (114th)

Consumer Issues/Safety/Products CSP

Biosimilars ---Implementation of Affordable Care Act ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Biosimilar User Fee Act Reauthorization and Implementation ---Colombia Biologics Regulations ---Access to Samples for Testing ---S.3056: Creating and Restoring Equal Access to Equivalent Samples Act of 2016 Drug Importation ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to Restrict FDA Approval of GE Salmon ---Labeling ---S. 2634: The One Health Act ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Review and Labeling of Food Derived from Biotechnology ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---S. 764: Senate biotech labeling compromise bill ---S.2609: The Biotech Labeling Solutions Act USDA/APHIS Agricultural Biotechnology Regulations ---Co-existence of Production Systems ---Efficient Science-Based Review of Biotech Products ---Potential Revisions to Part 340 Regulations

Contacted: Agriculture, Dept of (USDA); Health & Human Services, Dept of (HHS); White House Office; Centers For Medicare and Medicaid Services (CMS); Office of Science & Technology Policy (OSTP); Natl Institutes of Health (NIH); SENATE; Natl Security Council (NSC); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Environmental Protection Agency (EPA); Health Resources & Services Administration (HRSA); Food & Drug Administration (FDA)

Bills named: S. 2609 (114th), S. 764 (114th), S. 2634 (114th), H.R. 5325 (114th), S. 2956 (114th), S. 3056 (114th), H.R. 5054 (114th), H.R. 1599 (114th), S. 3040 (114th)

Food Industry (safety, labeling, etc.) FOO

Food Waste ---H.R. 4184: The Food Recovery Act Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to Restrict FDA Approval of GE Salmon ---Labeling ---S. 2634: The One Health Act ---H.R.505/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 Review and Labeling of Food Derived from Biotechnology ---H.R. 1599: Safe and Accurate Food Labeling Act of 2015 ---S. 764: Senate biotech labeling compromise bill ---S. 2609: The Biotech Labeling Solutions Act

Contacted: Centers For Medicare and Medicaid Services (CMS); Health Resources & Services Administration (HRSA); Office of Science & Technology Policy (OSTP); Environmental Protection Agency (EPA); HOUSE OF REPRESENTATIVES; White House Office; U.S. Trade Representative (USTR); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); Agriculture, Dept of (USDA); Natl Institutes of Health (NIH); SENATE; Natl Security Council (NSC)

Bills named: S. 2634 (114th), S. 764 (114th), H.R. 505 (114th), H.R. 1599 (114th), S. 2956 (114th), S. 2609 (114th), H.R. 4184 (114th)

Animals ANI

Genetically Engineered (GE) Animals ---Amendment on GE Salmon Labeling ---Amendment to Restrict FDA Approval of GE Salmon ---Labeling ---H.R.5054/S.2956: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2017 ---S. 2634: The One Health Act

Contacted: White House Office; Health Resources & Services Administration (HRSA); Office of Science & Technology Policy (OSTP); Health & Human Services, Dept of (HHS); U.S. Trade Representative (USTR); SENATE; Natl Security Council (NSC); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Environmental Protection Agency (EPA); Agriculture, Dept of (USDA); Natl Institutes of Health (NIH)

Bills named: S. 2634 (114th), S. 2956 (114th), H.R. 5054 (114th)

Medical/Disease Research/Clinical Labs MED

Biodefense Research, Development and Procurement Issues (Nonfunding) ---S. 2055/H.R. 3299: Medical Countermeasures Innovation Act Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Funding for Combating Antibiotic-Resistant Bacteria (CARB) Initiative ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Funding for National Institutes of Health ---H.R.5325/S.3040: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 ---Supplemental Funding for Combating Zika ---H.R. 2577: The Zika Response Appropriations Act of 2016 Gene Editing Technologies ---S.3040-H.R.5325: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017 Precision Medicine Initiative Senate Innovation for Healthier Americans ---Longitudinal Study of Chronic Diseases Combating Antibiotic-Resistant Bacteria (CARB) Initiative

Contacted: U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS); Natl Security Council (NSC); Agriculture, Dept of (USDA); Environmental Protection Agency (EPA); SENATE; Food & Drug Administration (FDA); Health Resources & Services Administration (HRSA); Centers For Medicare and Medicaid Services (CMS); White House Office; HOUSE OF REPRESENTATIVES; Office of Science & Technology Policy (OSTP); Natl Institutes of Health (NIH)

Bills named: H.R. 5325 (114th), H.R. 3299 (114th), H.R. 2577 (114th), S. 2055 (114th), S. 3040 (114th)

Science/Technology SCI

Synthetic Biology Issue ---H.R. 591: Engineering Biology Research and Development Act Review of the Federal Coordinated Framework for Biotechnology Products Gene Editing Technologies ---S.3040-H.R.5325: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2017

Contacted: Health & Human Services, Dept of (HHS); Health Resources & Services Administration (HRSA); Food & Drug Administration (FDA); SENATE; Environmental Protection Agency (EPA); White House Office; Centers For Medicare and Medicaid Services (CMS); U.S. Trade Representative (USTR); HOUSE OF REPRESENTATIVES; Agriculture, Dept of (USDA); Natl Institutes of Health (NIH); Office of Science & Technology Policy (OSTP); Natl Security Council (NSC)

Bills named: H.R. 591 (114th), H.R. 5325 (114th), S. 3040 (114th)